Cardiovascular DiseaseNCT00441714
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
A study testing repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise in people with Cardiovascular Disease and Ischemia-reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients. To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Ischemia-reperfusion Injury, Postconditioning
- What is being tested?
- repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- No physical limitation to perform ischemic exercise
- Informed consent
Who cannot join
- Diabetes (fasting glucose > 7,0mmol/l, or random glucose >11,0mmol/l)
- hyperlipidemia (random total cholesterol > 6.5 mmol/l)
- Hypertension (supine SBP/DBP > 140/90 mmHg at screening)
- Any cardiovascular disease
- Drug abuse
- Concomitant chronic use of medication
- Administration of radioactivity in research setting during the last 5 years
- Participation to any drug-investigation during the previous month as checked with VIP check according to CRCN standard procedures.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients.
To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping.
Read the detailed description
Recently, ischemic postconditioning has been identified as a protective intervention against ischemia-reperfusion injury. In animal studies, the signalling pathway of this (impressive) protective phenomenon is very similar to ischemic preconditioning. It opens a new avenue of post-reperfusion interventions with drugs that have been shown to mimic ischemic preconditioning. Before we can study this phenomenon in our forearm ischemia-reperfusion model, we need additional validating experiments. The purpose of this study proposal is to provide these data.
- Being tested
- repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise
- Keywords
- cardiovascular disease, ischemia-reperfusion injury, postconditioning, annexin targeting
- Medical subject headings
- Cardiovascular Diseases, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exerciseProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
Secondary outcomes (1)
Workload during (ischemic) exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startOct 2007
- Study completionDec 2007 (estimated)
Why it stopped: new insights have let us to expect marginal annexin targeting with a 10 minutes delay between reperfusion and administration of Annexin A5
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Gerard Rongen, MD PhD, Principal investigator, RUMCN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441714
- Sponsor's protocol ID
- IPost
- Status last verified
- Nov 2015
- First submitted
- 28 Feb 2007
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
PubMed 15623546
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
- ClinicalTrials.gov ID
- NCT00441714
- Acronym / sponsor ID
- IPost
- Keywords
- cardiovascular disease, ischemia-reperfusion injury, postconditioning, annexin targeting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: new insights have let us to expect marginal annexin targeting with a 10 minutes delay between reperfusion and administration of Annexin A5
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients.
To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping.
Detailed description
Recently, ischemic postconditioning has been identified as a protective intervention against ischemia-reperfusion injury. In animal studies, the signalling pathway of this (impressive) protective phenomenon is very similar to ischemic preconditioning. It opens a new avenue of post-reperfusion interventions with drugs that have been shown to mimic ischemic preconditioning. Before we can study this phenomenon in our forearm ischemia-reperfusion model, we need additional validating experiments. The purpose of this study proposal is to provide these data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50 years
- No physical limitation to perform ischemic exercise
- Informed consent
Key exclusion criteria (8 listed)
- Diabetes (fasting glucose > 7,0mmol/l, or random glucose >11,0mmol/l)
- hyperlipidemia (random total cholesterol > 6.5 mmol/l)
- Hypertension (supine SBP/DBP > 140/90 mmHg at screening)
- Any cardiovascular disease
- Drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise | Procedure or surgery | – |
Primary outcome
Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
1 secondary outcome
Workload during (ischemic) exercise.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Background: PubMed 15623546Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Rongen, MD PhD principal investigator
RUMCN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise in people with Cardiovascular Disease and Ischemia-reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.